The present invention relates generally to injectors, injector systems and control of injectors and injector systems, and, especially, to injectors, injector systems and injector control for use in medical procedures in which a fluid is injected into a patient.
In many medical diagnostic and therapeutic procedures, a physician or other person injects a patient with a fluid. In recent years, a number of injector-actuated syringes and powered injectors for pressurized injection of fluids such as contrast media have been developed for use in procedures such as angiography, computed tomography, ultrasound and NMR/MRI. In general, these powered injectors are designed to deliver a preset amount of contrast media at a preset flow rate.
To ensure the safety of the patient, the operation of a powered injector should be carefully controlled. For example, it is desirable not to exceed a certain fluid pressure during an injection procedure. In addition to potential hazards to the patient (for example, vessel damage) and potential degradation of the diagnostic and/or therapeutic utility of the injection fluid, excessive pressure can lead to equipment failure. For example, because of the potential of cross-contamination between patients, the syringe and tubing used to carry fluid to a patient are typically changed on a per-patient basis. Such disposable syringes and other fluid path components (sometimes referred to collectively as a xe2x80x9cdisposable setxe2x80x9d) are typically fabricated from plastics of various burst strengths. If the injector causes pressure in the fluid path to rise above the burst strength of a disposable fluid path element, the fluid path element will fail.
In controlling system or injection pressure, current injectors use motor current as an indication of system pressure. This technique has inherent accuracy problems, as there are many variables between the parameter being measured (motor current) and the parameter of interest (fluid pressure). These include, for example, measurement inaccuracies, motor torque constant variation, motor variation with temperature, frictional effects in the drive train, and frictional effects in the syringe. In general, any control algorithm must allow for such errors and must make a conservative estimate of fluid pressure to prevent actual fluid pressure from reaching a hazardous value.
Current systems typically predefine a conservative pressure (that is, motor current) control value. As the preset pressure control level is reached, such injectors begin to slow down the flow rate of injection in an effort to stop the build up pressure. At that point, an injector system that was originally intended to servo control the volume and flow rate of the injection fluid begins to servo control pressure. The inaccuracies inherent in using motor current to derive pressure result in a compliant system, and the operation of the servo in that state is oscillatory. Pressures in excess of desirable limits can occur, resulting in potentially hazardous operation of the injector.
In addition to problems of control with current injector systems, many such systems lack convenience and flexibility in the manner in which the injector systems must be operated. In that regard, the complexity of medical injection procedures and the hectic pace in all facets of the health care industry place a premium on the time and skills of an operator.
It is thus very desirable to develop injectors exhibiting improved operative control as well as injectors exhibiting improved ease of use.
In one aspect, the present invention provides an injector for use in injecting a fluid in a medical injection procedure. The injector includes a drive mechanism to pressurize the fluid; a sensor to measure a variable that is proportional to fluid pressure (that is, a direct or indirect measurement of fluid pressure); and a pressure monitor (for example, including hardwired circuitry and/or software) in communication with the sensor and the drive mechanism to stop the injection procedure when the sensor measures a value of the variable that corresponds to a pressure hazard limit.
Preferably, the pressure monitor further limits power input to the drive mechanism to a power limit once the variable reaches a value that corresponds to a power limiting pressure that is below the pressure hazard limit. In this manner, the pressure hazard limit should never be reached. If, however, the power limiting feature fails, the injector terminates the injection procedure once the pressure hazard limit is reached.
The drive mechanism may, for example, receive power from a motor. In this embodiment, the sensor can, for example, measure motor current. The pressure monitor can limit the motor current to a value corresponding to the power limiting pressure. The power limit is typically predetermined or preset for the injector in this embodiment.
In another embodiment, a more direct and accurate manner of measuring fluid pressure than measuring motor current is used. In one embodiment, for example, the sensor measures force exerted upon a component of the drive mechanism or an injector component in connection with the drive mechanism. In general, the sensor can measure force upon any component of the injector that bears a load proportional to the fluid pressure. Particularly in the case that a force sensor (for example, a strain gauge) or pressure transducer is used to measure fluid pressure, setting of the power limit during injector use and periodic auto-recalibration are facilitated.
In another aspect, the present invention provides an injector for use in injecting a fluid in a medical injection procedure including: a drive mechanism to pressurize the fluid; a sensor to measure a variable that is proportional to fluid pressure; and a pressure monitor in communication with the sensor and the drive mechanism to limit power input to the drive mechanism to a power limit once the variable reaches a value that corresponds to a power limiting pressure.
In a further aspect, the present invention provides an injector system for use in injecting a fluid in a medical injection procedure including a drive mechanism to pressurize the fluid and a control mechanism to control flow rate of the fluid and volume of the fluid injected. The injector further includes a sensor including a force transducer providing a measure of fluid pressure and a pressure monitor in communication with the sensor and the drive mechanism to stop the injection procedure when the sensor measures a pressure corresponding to a pressure hazard limit. The pressure monitor also preferably limits power input to the drive mechanism to a power limit when the sensor measures a pressure corresponding to a power limiting pressure. As discussed above, the power limiting pressure is less that the pressure hazard limit.
In another aspect, the present invention provides an injector system for use in injecting a fluid in a medical injection procedure including a drive mechanism to pressurize the fluid and a control mechanism to control flow rate of the fluid and volume of the fluid injected (typically on the basis of flow rate and volume setting input by the user of the injector using a data entry mechanism as known in the art). The injector also includes a safety system including a sensor (for example, a force transducer) to provide a measure of fluid pressure. The safety system also includes a pressure monitor in communication with the sensor and the drive mechanism. The pressure monitor is adapted to override settings of the control mechanism and stop the injection procedure when the sensor measures a pressure corresponding to a pressure hazard limit. Moreover, the pressure monitor is adapted to override settings of the control mechanism to limit power input to the drive mechanism to a power limit when the sensor measures a pressure corresponding to a power limiting pressure, the power limiting pressure being below the pressure hazard limit. In general, the power limit is preferably the power being supplied to the drive mechanism when the power limiting pressure is measured.
In a further aspect, the present invention provides a method of controlling an injector used in a medical injection procedure. The method includes the steps of:
measuring a variable that is proportional to fluid pressure; and
limiting power input to a drive mechanism of the injector to a power limit once the variable reaches a value that corresponds to a power limiting pressure.
The method may also include the step of:
terminating the injection procedure if the value of the variable corresponds to a pressure hazard limit, the pressure hazard limit being greater than the power limiting pressure.
In another aspect, the present invention provides an injector for use with a syringe having a plunger disposed therein to inject a fluid in a medical procedure. The injector includes:
a control unit including a control unit housing and control circuitry disposed within the control unit housing; and
at least one syringe interface module including, a module housing, at least one syringe interface on the module housing that is adapted to connect the syringe to the module housing and at least one drive member within the module housing to control motion of the plunger, the module housing being moveable relative to the control unit housing.
In one embodiment the module housing is rotatable relative to the control unit housing. In another embodiment the module housing is physically detached from the control unit housing.
In still a further aspect, the present invention provides a system for performing a medical imaging procedure including:
an injector, the injector including a portable remote control panel;
an imaging apparatus; and
an attachment member in the vicinity of (or attached to) the imaging apparatus, the attachment member being adapted to attach or support the remote control panel in the vicinity of the imaging apparatus to facilitate generally simultaneous access by the operator to both the remote control panel and the imaging apparatus while performing the medical imaging procedure.
In another aspect, the present invention provides an injector for use in injecting a fluid in a medical injection procedure including a drive having a motor to pressurize the fluid; a sensor to provide a measure of fluid pressure; and a pressure monitor in communication with the sensor and the drive to stop the motor using 4-quadrant control when the sensor communicates a measured pressure of at least a pressure hazard limit. The pressure monitor also limits power input to the motor to a power limit once the sensor communicates a measured pressure of at least a power limiting pressure as described above. As also described above, the power limiting pressure is below the pressure hazard limit.
In another aspect, the present invention provides an injector system including a motor to pressurize the fluid; a servo controller in communication with the motor; a sensor including a force transducer to provide a measure of fluid pressure; and a pressure monitor in communication with the sensor and the servo controller to stop the motor using 4-quadrant control when the sensor measures a pressure of at least a pressure hazard limit. Once again, the pressure monitor preferably also limiting power input to the motor to a power limit when the sensor measures a pressure corresponding to a power limiting pressure, which is less than the pressure hazard limit.
In another aspect, the present invention provides an injector system including a motor to pressurize the fluid; a servo controller in communication with the motor; a sensor in communication with the servo controller including a force transducer to provide a measure of fluid pressure; and a safety monitoring system in communication with the sensor. The safety monitoring system is also in communication with the servo controller and sets a pressure hazard limit. The safety monitoring system communicates the pressure hazard limit to the servo controller. The servo controller stops the motor using 4-quadrant control when the sensor communicates a fluid pressure measurement of at least the pressure hazard limit.
Preferably, the safety monitoring system also sets a power limiting pressure that is less than the pressure hazard limit and communicates the power limiting pressure to the servo controller. The servo controller limits the power to the motor when the sensor communicates a measured pressure of at least the power limiting pressure.
In still another aspect, the present invention provides a method of controlling an injector system for use in a medical injection procedure including the steps of: measuring a variable that is proportional to fluid pressure; limiting power input to a motor of the injector to a power limit once the variable reaches a value corresponding to at least a power limiting pressure; and stopping the motor using 4-quadrant control if the variable reaches a value corresponding to at least a pressure hazard limit, the pressure hazard limit being greater than the power limiting pressure.
Numerous other objects and advantages of the present invention will be apparent from the following drawings and detailed description of the invention and its preferred embodiments.